FDA Inspection
Mr. Darius F. MirzaMr. Darius F. Mirza – FDA Inspection, Dec 16, 2009
Record Details
This FDA Inspection record concerns Mr. Darius F. Mirza, with an inspection on December 16, 2009, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Mr. Darius F. Mirza
- Inspection Date
- December 16, 2009
- Product Type
- Biologics
View Company Profile
ID · d13755a1-f189-4c75-8af4-6d7ba8a87d44
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 635434
- FDA center
- Biologics
- Project area
- Bioresearch Monitoring
FDA Citations
4- 21 CFR 312.60FD-1572, protocol compliance
- 21 CFR 312.61Unauthorized recipients (investigator)
- 21 CFR 312.60Informed consent
- 21 CFR 312.62(b)Case history records- inadequate or inadequate
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